Oil Pulling Whitening Mouthwash

NCT07667088 | Recruiting

• 1 other identifier: STUDY00001211
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the tooth whitening efficacy of Oil Pulling oral rinse compared to a competitor's whitening mouthwash and a water-based mouthwash (placebo). Each participant will use one of three mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo). All mouthwashes will be used once daily last thing before bed at night. Data will be collected on tooth shade evaluated on the anterior teeth.

Conditions

Healthy Adult Participants; Tooth Stain

Keywords

tooth whitening; tooth stains; oil pulling; mouthwash; mouth rinse; stain removal

Outcome Measures

Primary Outcomes (3)

• Measurement by the VITA Easyshade Advance 4.0

  A probe tip is placed on an area of the enamel surface that has underlying dentin and a measurement made of the shade

  Baseline to 8 weeks

• VITA Bleachguide 3-D Master Shade Guide

  A single examiner will perform visual tooth shade assessment under standard lighting conditions. Tooth shade will be scored on selected anterior teeth . The tab marking system includes interpolated shade guide units (sgu) ranging from 1 to 29 sgu with a lower score indicating more whitening. Subject shade rank scores will be determined for each visit by calculating the mean value across the selected anterior teeth scored.

  Baseline to 8 weeks

• Lobene Stain Index

  Measure of intensity and extent of extrinsic stain on the facial surfaces of 12 anterior teeth. The teeth are divided into regions which are scored separately. Intensity is scored from 0 (no stain) to 3 (heavy stain; dark brown to black) and extent is scored from 0 (no stain) to 3 (stain covering over two-thirds of the region). Scores will be averaged for each subject for intensity (sum of all intensity scores/all sites graded) and extent (sum of all extent scores/all sites graded), and the composite stain score calculated by multiplying the mean stain intensity by the mean stain extent.

  Baseline to 8 weeks

Secondary Outcomes (2)

• Satisfaction: Subjective participant questionnaires

  8 weeks

• Satisfaction Questionnaire

  8 weeks

Study Arms (3)

Test Product

EXPERIMENTAL

Dietary Supplement: GuruNanda natural Oil Pulling oral rinse

Positive Control

ACTIVE COMPARATOR

Dietary Supplement: Therabreath Whitening Mouthwash - Dazzling Mint

Negative Control

PLACEBO COMPARATOR

Dietary Supplement: GuruNanda water-based non-whitening mouthwash

Interventions

Therabreath Whitening Mouthwash - Dazzling Mint DIETARY_SUPPLEMENT

positive control

Positive Control

GuruNanda water-based non-whitening mouthwash DIETARY_SUPPLEMENT

negative control

Negative Control

GuruNanda natural Oil Pulling oral rinse DIETARY_SUPPLEMENT

Test product

Test Product

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult subjects aged 18-60, that are in good health.
• Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator.
• Subject's front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachguide 3D-Master and the Vita EasyShade device.
• Subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
• The subjects should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other teeth whitening technologies during this period.
• The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.

You may not qualify if:

• Pregnant or nursing by subject report.
• Any active condition in the oral cavity at the discretion of the investigator.
• Any surgery or dental procedure in the treated area within 3 months prior to treatment, or before complete healing.
• Subjects that do not brush regularly.
• Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator.
• Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.
• Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.
• Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine).
• Participation in another clinical trial within the last 30 days.
• Presence of orthodontic appliances, except for removable retainers.
• Signs of advanced enamel wear, dentin exposure, or tooth fractures.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• GuruNanda LLC: collaborator

Study Sites (1)

Clinical Research Facility of the Center for Oral Health and Research, UTHSA

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Bennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI

CONTACT

210-567-3185; amaechi@uthscsa.edu

Razina Vohra

CONTACT

210-643-9803; vohrar@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To facilitate double blinding, only the Randomizer will dispense the products, give instructions on the use of the products, and supervise the first use of the product at the clinical facility. The clinical Examiner and other study team members will not discuss product-use with the subjects.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Cariology, Department of Comprehensive Dentistry

Model Details: This is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group prospective clinical trial.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)